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CTRI Number  CTRI/2025/07/091741 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Study Comparing How Three Different Mouthwashes Affect Cavity-Causing Germs and Plaque in Children Aged 8 to 10 Years 
Scientific Title of Study   Comparative Evaluation Of Effect Of Three Different Mouthwashes On Salivary Streptococcus mutans And Streptococcus salivarius Count And Plaque Level In Children Between Age 8-10 Years: A Clinical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Balaji Gawade  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasanna Dahake 
Designation  Professor & PG Guide 
Affiliation  Maharashtra Institute of Dental Sciences and Research, Latur 
Address  Room No.6, Ground Floor, Maharashtra Institute Of Dental Sciences And Research, Latur - 413512, Maharashtra

Latur
MAHARASHTRA
413512
India 
Phone  9545356010  
Fax    
Email  prasannadahake@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Balaji Gawade 
Designation  Postgraduate Student 
Affiliation  Maharashtra Institute of Dental Sciences and Research, Latur 
Address  Room No.6, Ground Floor, Maharashtra Institute Of Dental Sciences And Research, Latur - 413512, Maharashtra

Latur
MAHARASHTRA
413512
India 
Phone  8766532626  
Fax    
Email  balagawade1996@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Balaji Gawade 
Designation  Postgraduate Student 
Affiliation  Maharashtra Institute of Dental Sciences and Research, Latur 
Address  Room No.6, Ground Floor, Maharashtra Institute Of Dental Sciences And Research, Latur - 413512, Maharashtra

Latur
MAHARASHTRA
413512
India 
Phone  8766532626  
Fax    
Email  balagawade1996@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra Institute of Dental Sciences and Research, Latur- 413512, Maharashtra 
 
Primary Sponsor  
Name  Balaji Gawade 
Address  Room NO. 6, Ground Floor, Maharashtra Institute of Dental Sciences and Research, Latur - 413512, Maharashtra 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanna Dahake  MIDSR Dental College  Room No. 6, Ground Floor, Maharashtra Institute of Dental Sciences and Research, Latur - 413512, Maharashtra
Latur
MAHARASHTRA 
9545356010

prasannadahake@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharashtra University of Health Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with positive/definitely positive Frankl behaviour.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine Mouthwash  chlorhexidine as been the gold standard mouthwash. It is a cationic bisguanide, with a broad-spectrum antibacterial effect by virtue of its high intra oral substantivity and bactericidal and bacteriostatic activity.  
Intervention  Cocoa Bean Husk Extract  The incorporation of cocoa powder or chocolate into hamster diets was reported to reduce caries. Subsequently it was suggested that phenolic substances could be responsible for the observed anti-caries effect of cocoa powder. The cocoa bean husk is a by product material generated in the chocolate industry. It has been shown to possess two types of cariostatic sub stances, one showing anti-glycosyltranferase activity and the other antibacterial activity. 
Intervention  Hydroalcoholic Extract Of Pomegranate   recent herbal products is Punica granatum, which literally translates to seeded (“granatus”) apple (“pomum”). Punica granatum Linn belongs to family Punicaceae, mostly known as “pomegranate.” It is a shrub native from Asia where several of its parts have been used as an astringent, haemostatic, and for diabetes control. This is also known to show antibacterial properties 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Patients of age between 8-10 yrs.
Patients with positive/definitely positive Frankl behaviour.
Good systemic health, no antibiotic intake within the past 3 weeks
before the study onset.
Absence of oral habit.
No use of orthodontic or prosthetic appliances, no xerostomia, no
periodontal disease.
Absence of active caries in the buccal and lingual surfaces of
maxillary right first molar, mandibular left first molar, maxillary left
lateral incisor, mandibular right lateral incisor, maxillary right
central incisor, and mandibular left central incisor teeth.  
 
ExclusionCriteria 
Details  Children with special care needs, and those with intellectual
disabilities.
Patients undergoing any surgical treatment or who recently
underwent topical fluoride application.
Patients having a history of allergy to any of the components of
mouthrinse used.
Patients whose parents/guardians/heads of the institution have
not consented for permission.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cocoa bean husk extract, pomegranate extract and chlorhexidine mouth
wash reduces dental plaque formation among children between age of 8
to 10 years. 
1 year 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Cocoa bean husk extract, pomegranate extract and chlorhexidine
mouthwash has no effect in reduction of dental plaque formation among
children between age of 8 to 10 years.  
1 year, 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   07/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE:-

COMPARATIVE EVALUATION OF EFFECT OF THREE DIFFERENT MOUTH WASHES ON SALIVARY STREPTOCOCCUS MUTANS AND STREPTOCOCCUS SALIVARIUS COUNT AND PLAQUE LEVEL IN CHILDREN BETWEEN AGE 8-10 YEARS: A CLINICAL STUDY

INTRODUCTION:-

Oral hygiene and it’s persistent maintenance by children has always been a challenge for the family and dental professionals. The dental caries and the plaque accumulation leads to imbalanced dental health. The main cause of dental caries is attributed to dental plaque. The oral flora consists more than 350 cultivable species. Historically, natural products have been used since ancient times and in the folklore for treatment of many diseases and illnesses. Various products such as turmeric, camphor, clove oil are sought to relieve pain caused due to odontogenic infections, whereas pomegranate, cocoa husk extract, ginger, neem, tulsi, amla, triphala and aloe-vera, are proven to reduce S. mutans(Streptococcus Mutans) counts when used as mouth rinses. Natural, organic, and herbal mouth rinses do not contain alcohol, artificial preservatives, or colours and flavours, and have unique therapeutic properties. Hence, they are attaining popularity among today’s relatively more aware consumers. S. salivarius(Streptococcus salivarius) is one of the first colonizers of the human oral cavity and gut after birth and therefore may contribute to the establishment of immune homeostasis and regulation of host inflammatory responses. Various agents have been used to control dental caries forming bacteria as well as for plaque reduction. These include dental varnishes, mouthwash, toothpaste, dentifrices and other mechanical agents too. Mouthwashes have been found to be one of the safe and effective delivery system as anti-microbial and antiplaque agents. These mouthwashes are capable of inhibiting bacterial adhesion, colonization and metabolic  activity which ultimately affects bacterial growth. Amongst all, chlorhexidine as been the gold standard mouthwash. It is a cationic bisguanide, with a broad-spectrum antibacterial effect by virtue of its high intra oral substantivity and bactericidal and bacteriostatic activity. However, prolonged use of chlorhexidine has led to tooth discolouration in many children so, various herbal extract mouthwashes has been attempted to help reduce the incidence of dental caries and plaque accumulation. One of the recent herbal products is Punica granatum, which literally translates to seeded (“granatus”) apple (“pomum”). Punica granatum Linn belongs to family Punicaceae, mostly known as “pomegranate.” It is a shrub native from Asia where several of its parts have been used as an astringent, haemostatic, and for diabetes control. The genus name, Punica, was the Roman name for Carthage, where the best pomegranates were known to grow. The incorporation of cocoa powder or chocolate into hamster diets was reported to reduce caries. Subsequently it was suggested that phenolic substances could be responsible for the observed anti-caries effect of cocoa powder. The cocoa bean husk is a by product material generated in the chocolate industry. It has been shown to possess two types of cariostatic sub stances, one showing anti-glycosyltranferase activity and the other antibacterial activity. In the literature there are no studies evaluating the comparative effects of cocoa bean husk, pomegranate and chlorhexidine mouthwash in reduction of S. mutans and S. salivarius in saliva and its clinical effect on dental plaque formation in young children. The purpose of this study is to compare the effects of cocoa bean husk, pomegranate and chlorhexidine mouthwash on levels of Streptococcus mutans and streptococcus salivarius in the saliva and its clinical effect on dental plaque formation of the children between age of 8 to 10 years old.

METHODOLOGY:-

 

Study Design:

Type: Clinical observational study

Duration: 18 months (12 months data collection + analysis)

Setting: Departments of Pediatric Dentistry, Microbiology, and Pharmaceuticals

 

Participants:

Age Group: 8–10 years

Sample Size: 30 children (10 per group)

Sampling: Random allocation using AI-generated table

Groups:

Group A: 0.2% Chlorhexidine (positive control)

Group B: 0.1% Cocoa Bean Husk Extract (CBHE)

Group C: 38% Hydroalcoholic Pomegranate Extract

 

Eligibility Criteria:

Inclusion: Healthy children with cooperative behavior, no recent antibiotics, no active caries or oral appliances

Exclusion: Special needs, recent surgery or fluoride treatment, known allergies, or lack of consent

 

Study Procedure:

Phase I – Microbial Evaluation:

Saliva Collection: Baseline & after 7 days in 3 stages (with 15-day washout)

Testing: Saliva cultured on Mitis Salivarius agar for S. mutans and S. salivarius CFU count

Tools: Sterile cups, culture plates, CFU counter

Phase II – Clinical Plaque Evaluation:

Index Used: Simplified Oral Hygiene Index (OHI-S)

Tools: Mouth mirror and explorer

Procedure: Plaque and calculus scored on 6 teeth surfaces; OHI-S calculated at same intervals as saliva

 

Preparation of Mouthwashes:

CBHE: Extracted using ethanol and lyophilized; sweetened with saccharin

Pomegranate: Hydroalcoholic extract from crushed fruit, filtered and concentrated

 

Mouthwash Use Instructions:

10 ml, twice daily for 7 days per stage

No food/drink for 30–45 minutes post-use

Blinded bottles coded for data masking

Latin square design used for sequence control 


And then Streptococcus mutans count and Streptococcus salivarius count will be assessed and analysed at baseline and after intervention

 

 
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